Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06343116
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-03-18
Brief Title:
Nimotuzumab Combined With TrifluridineTipiracil in the Treatment of Refractory Metastatic Colorectal Cancer
Sponsor:
Biotech Pharmaceutical Co Ltd
Organization:
Biotech Pharmaceutical Co Ltd
Study Overview
Official Title:
Randomized Double-blind Placebo-controlled Multicenter Clinical Study of Nimotuzumab Combined With TrifluridineTipiracil in Third-line and Beyond for the Treatment of Metastatic Colorectal Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NOTABLE-308
Brief Summary:
This is a randomized double-blind placebo-controlled multicenter study The main purpose of the study is to evaluate the clinical efficacy and safety of nimotuzumab combined with trifluridinetipiracil in third-line and beyond for the treatment of metastatic colorectal cancer mCRC This study planned to be divided into two parts Part A and Part B Part A safety run-in with a 3 3 study design which primary endpoint is safety Part B main study with a prospective randomized double-blind placebo-controlled design which primary endpoint is overall survival OS
Detailed Description:
This is a randomized double-blind placebo-controlled multicenter study The main purpose of the study is to evaluate the clinical efficacy and safety of nimotuzumab combined with trifluridinetipiracil in third-line and beyond for the treatment of metastatic colorectal cancer mCRC This study planned to be divided into two parts Part A and Part B Part A is a dose escalation study and two dose levels are set up in terms of the dose of nimotuzumab dose level 1 nimotuzumab 400 mg weekly dose level 2 nimotuzumab 600 mg weekly while the dose of trifluridinetipiracil remains unchanged The aim of this part is to investigate the safety of combination therapy and ensure the dose of nimotuzumab in Part B After completed the safety-run-in of Part A Part B can be started In Part B main study a prospective randomized double-blind placebo-controlled design is proposed Patients of this part will be stratified by tumor site left half of colorectal vs right half of colon age less than 65 years old vs 65 years old or older and number of metastases 3 vs 3 and randomly divided into experimental group nimotuzumab plus trifluridinetipiracil and control group placebo plus trifluridinetipiracil at a ratio of 21 Treatment will continue until disease progression or intolerable toxicity or withdrawal of consent In part B the primary endpoint is overall survival OS the secondary endpoint included Progression free survival PFS time to progress TTP overall response rate ORR disease control rate DCR duration of response DoR quality of life QoL etc
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None